Pharmaceutical Formulation Development

Quality by Design Drives Our Pharmaceutical Formulation Development

Across dosage forms, LGM Pharma has mastered product development for FDA approval

When it comes to outsourcing your molecule for formulation development, look for a CDMO partner with a track record of regulatory approvals and successful commercial launches. LGM Pharma has proven we can formulate your next generic or innovator drug using Quality by Design (QbD) principles to gain FDA approval.

We take pride in formulating for patient safety, efficacy, and compliance while meeting our sponsor’s timelines, budgets, and business requirements. That means hitting your milestones to enhance speed-to-market.

Formulating for Commercial Success

Put your formulation on the fast track for regulatory and commercial success. LGM Pharma’s efforts to integrate product development and regulatory, while consistently focusing on quality, ensures the formulations we develop are safe and efficacious. And backed by documentation to support regulatory approval. The design space and manufacturing processes are also developed and validated to scale for commercialization.

Formulation and Development Capabilities

Working in state-of-the-art laboratories, PhD formulators, analytical chemists, and technicians with decades of experience develop and validate a robust drug product formulation and manufacturing process. Development is based on sound science to yield reproducible safety, efficacy, and stability profiles.

Informed by FDA requirements, our formulators learn everything there is to know about your drug product and what’s required to manufacture it. That includes identifying, understanding, and selecting all controls to achieve the intended design and regulatory approval.

Integrating Product Development and Regulatory Submissions

To truly gain the benefits of Quality by Design (QdD) – improved cost control, greater speed to market, improved ROI – product development and regulatory considerations must go hand-in-hand.

Rather than having siloed formulations and regulatory teams, our experts collaborate – from project selection and risk assessment of the Target Product Profile through to submission and tech transfer for commercial manufacturing in our cGMP facilities in California and Texas.

Process for Integrated Product Development and Regulatory Submissions

Our integrated Product Development and Regulatory process resulted in 4 regulatory approvals and 3 successful commercial launches in a recent 12-month period.

Choose LGM for excellence in pharmaceutical formulation development

In addition to our QbD development process and integrated approach, we offer the full complement of expected formulation services in-house, including formulation of controlled substances, analytical testing, and the latest formulation manufacturing processes.

  • Analytical methods development and validation
    • Identification of Analytical Target Profiles and Critical Quality Attributes
  • Process development and validation
  • Stability studies
    • Stability chambers meet the full range of ICH environment requirements
    • Stability-indicating assay methods for all pharmaceutical dosage forms

LGM Pharma employs the most effective and latest formulation manufacturing processes:

  • Low shear wet granulation process
  • High shear wet granulation process
  • Spray granulation process
  • Dry granulation process
  • Bead layering and coating
  • Modified/extended/immediate/controlled/timed release
  • Coating of powders and granules
  • Tablet /capsule coating
  • Low and medium viscosity liquid mixing
  • Encapsulation of powder, tablets, or beads
  • Encapsulation of tablets with beads or powder
  • Bi-layer tableting (coming soon)